Rasha K. Al-Lamee1,2, MA, MBBS, PhD; Michael Foley1,2, BSc, MBBS; Christopher Rajkumar1,2, BSc, MBBS; Alexandra N. Nowbar1,2, BS, MBBS
1. National Heart and Lung Institute, Imperial College London, London, United Kingdom; 2. Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom
Placebo-controlled trials of interventional procedures present additional recruitment challenges compared to placebo-controlled drug trials and unblinded interventional trials. This is related to the additional risks a placebo intervention might pose to patients without any potential for physical therapeutic benefit. Patient reluctance to participate can lead to difficulty in recruiting to target and time.
Many reasons are cited by patients and medical teams when they decline to participate in placebo-controlled trials. However, educating patients and medical teams can alleviate concerns and ensure that, with fully informed consent, patients choose to participate in research that can be practice changing.